Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Transducer, Miniature Pressure
510(k) Number K915897
Device Name FPL
Applicant
Wrm Computers
P.O. Box 384
7940 Aj Meppel
Holland,  HN
Applicant Contact WILFRED MAURITS
Correspondent
Wrm Computers
P.O. Box 384
7940 Aj Meppel
Holland,  HN
Correspondent Contact WILFRED MAURITS
Regulation Number890.1615
Classification Product Code
IKE  
Date Received11/25/1991
Decision Date 04/07/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-